Table 2. Most Common (≥10%) Noncardiovascular Treatment–Emergent Adverse Events (TEAEs).
Adverse event | Patients, No. (%) | |||
---|---|---|---|---|
Placebo group | Fenfluramine group | Overall | ||
0.2 mg/kg/d | 0.7 mg/kg/d | |||
No. of patients | 87 | 89 | 87 | 263 |
TEAE | ||||
Any | 65 (75) | 69 (78) | 78 (90) | 212 (81) |
Patients with ≥1 serious | 4 (5) | 4 (4) | 10 (11) | 18 (7) |
TEAEs ≥10% | ||||
Decreased appetite | 10 (11) | 18 (20) | 31 (36) | 59 (22) |
Somnolence | 9 (10) | 9 (10) | 15 (17) | 33 (13) |
Fatigue | 9 (10) | 8 (9) | 16 (18) | 33 (13) |
Pyrexia | 10 (11) | 9 (10) | 7 (8) | 26 (10) |
Diarrhea | 4 (5) | 10 (11) | 11 (13) | 25 (10) |
Vomiting | 5 (6) | 12 (13) | 7 (8) | 24 (9) |